Status:
COMPLETED
Phase II Neoadjuvant ER+/PgR + Arimidex +/- Iressa Study
Lead Sponsor:
AstraZeneca
Conditions:
Breast Cancer
Eligibility:
FEMALE
Phase:
PHASE2
Brief Summary
The purpose of this study is to compare the changes in a proliferation biomarker in subjects receiving Anastrozole or Anastrozole/ZD1839 combination.
Eligibility Criteria
Inclusion
- Measurable (stage I-IIIB) non meta static non inflammatory breast cancer
- Patients must post menopausal women who in the opinion of investigator would be likely to benefit from endocrine therapy. Postmenopausal patients are defined as:
- Natural menopause with last menses \> 1 year ago,
- Radiation induced oophorectomy with last menses \> 1 year ago,
- Serum FSH and LH levels clearly in the postmenopausal range for the institution.
- Bilateral oophorectomy
Exclusion
- Other current or previous (to last 5 years) malignancies, other metastases, abnormal blood chemistry, lung/ heart/kidney/liver abnormalities,
- Hormonal treatment within the last 2 weeks, previous hormonal treatment for invasive cancer
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
End Date :
November 1 2005
Estimated Enrollment :
185 Patients enrolled
Trial Details
Trial ID
NCT00255463
Start Date
January 1 2004
End Date
November 1 2005
Last Update
April 23 2009
Active Locations (34)
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1
Research Site
Brno, Czechia
2
Research Site
Chomutov, Czechia
3
Research Site
Ostrava, Czechia
4
Research Site
Ostrava - Poruba, Czechia